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Medically reviewed by Drugs.com. Last updated on Dec 26, 2017.

Dosage form: liquid
Ingredients: CODEINE PHOSPHATE 6.33mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 3.33mg in 5mL, BROMPHENIRAMINE MALEATE 1.33mg in 5mL
Labeler: R.A. McNeil Company
NDC Code: 12830-754

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

(in each 5 mL teaspoonful)


Brompheniramine Maleate 1.33 mg

Codeine Phosphate 6.33 mg

(WARNING: May be habit-forming)

Phenylephrine Hydrochloride 3.33 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • itching of nose or throat
  • runny nose
  • itchy, watery eyes
  • sneezing
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • may cause or aggravate constipation

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

Adults and children

12 years of age

and over:

3 teaspoonfuls every 4 to 6 hours,

not to exceed 18 teaspoonfuls in a

24 hour period

Children 6 to under

12 years of age:

1 1/2 teaspoonfuls every 4 to 6 hours,

not to exceed 9 teaspoonfuls in a

24 hour period

Children under 6

years of age

Not recommended for use

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

citric acid, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 354 mL label:

NDC 12830-0754-12


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Antihistamine · Antitussive

· Nasal Decongestant

Sugar Free · Alcohol Free


CV

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Brompheniramine Maleate ..........................1.33 mg

Codeine Phosphate.......................................6.33 mg
(WARNING: May be habit-forming.)

Phenylephrine Hydrochloride.......................3.33 mg

Cotton Candy Flavor
12 fl. oz. (354 mL)

Mfg. for:

R.A. McNeil Company
Chattanooga, TN 37406-3738

Rev. 10/14

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

This package not intended for dispensing to the patient.



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codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-754
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE6.33 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE3.33 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1.33 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12830-754-12354 mL in 1 BOTTLE
2NDC:12830-754-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/11/2008
Labeler - R.A. McNeil Company (008305220)
Registrant - Woodfield Pharmaceutical, LLC (079398730)
Establishment
NameAddressID/FEIOperations
Woodfield Pharmaceutical, LLC079398730manufacture(12830-754)

 
R.A. McNeil Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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